# K202170: LiverMultiScan

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum, Ltd.
- Decided: Oct 2, 2020 after 60 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K971684 (1997). 36 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190017: LiverMultiScan (LMSv3), Perspectum Diagnostics, Ltd. (2019) Summary page 4.

## Most influential descendants
- K213960: LiverMultiScan v5 (LMSv5) (2022), 1 descendant of its own
- K253413: LiverMultiScan (v6.0) (2026), 0 descendants of its own
- K203280: Hepatica v1 (Hepatica v1.0.0) (2021), 0 descendants of its own

## Indications for use
LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis

Source page: https://510kreport.com/device/K202170
Methodology: https://510kreport.com/methodology